Nom du site: UK – London – New Oxford Street, Mississauga
Data de publication: Oct 24 2024
Clinical Data Scientist
As a Clinical Data Scientist, you will be responsible for overseeing the end-to-end DS&M study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.
Key Responsibilities:
• Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan which include:
o Electronic Case Report Form, vendor data, and other clinical outcome assessments
o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
o Interim and final cleaned database lock
o Archival of all DM documents in the eTMF
o Archival of the study database and provision of clinical data to the study site
• For an in-house study, leads the day-to-day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters
• For study outsourced through a DM Functional Service Provider (FSP), conducts & documents DM sponsor oversight of the end-to-end FSP study related activities and ensures training on the protocol to the FSP resources working on the study. May oversee Full Service Outsourced (FSO) studies.
• Provides DM operational input into the study design, the protocol, study planning, study documents including the studyrisk register
• Provides reports, status updates, feedback and advice to key study stakeholders on study progress
• Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these
• Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity
• Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level
• Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s Degree, in scientific or business discipline
- Experienced in Clinical Data Management processes, standards and clinical systems
• Project Management
• Exposure to InForm, Rave/ Veeva/ OC, e-Diaries, e-Source is an added advantage
• Proficient in Microsoft exce and validation methodology
• Basic knowledge of PL SQL, SAS is an added advantage
• Understanding of general data flow & database architecture concepts
• Good understanding of regulations including ICH-GCP, 21 CRF part 11, CDISC requirement
• Comprehensive understanding of clinical drug /Vaccine development process
• Knowledge of medical terminology, anatomy and physiology
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
• Proven ability to prioritize and multi-task, along with effective time management skills • Detail oriented, organized
• Excellent interpersonal and teamwork skills
• Demonstrates adaptability and an agile mindset
• Problem solving mindset
• Quick learner
• Results oriented and customer focused
• Willing to work in a Global environment
Closing Date for Applications: 7th November 2024
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
Find out more:
Our approach to R&D.
En tant que société animée par nos valeurs de concentration sur le patient, de transparence, de respect et d’intégrité, nous savons que l’inclusion et la diversité sont essentielles à notre réussite. Nous voulons que tous nos collègues s'épanouissent chez GSK en apportant leurs expériences uniques, en s'assurant qu'ils se sentent bien et en poursuivant leur carrière. En tant que candidat à un poste, nous souhaitons que vous partagiez le même sentiment.
Nous sommes ouverts à tous les talents - quels que soient votre sexe, votre handicap, votre état civil ou votre religion. ou conviction, âge, race, orientation sexuelle, origine ethnique ou nationale.
Nous croyons en une culture de travail agile pour tous nos rôles. Si la flexibilité est importante pour vous, nous vous encourageons à explorer avec notre équipe d'embauche les opportunités qui se présentent.
N'hésitez pas à nous contacter si vous souhaitez discuter tout ajustement de notre processus susceptible de vous aider à démontrer vos forces et vos capacités. & nbsp; Vous pouvez nous appeler au 0808 234 4391 ou envoyer un e-mail à Ukdiversity.recruitment@gsk.com.
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